The purpose of this study is to compare conventional breast imaging and diagnostic work-up (2 dimensional imaging) to digital breast tomosynthesis (3 dimensional imaging) in the appearance of non-calcified breast masses. It is thought that non-calcified breast masses will be better visualized with the new 3D technology.

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

It is anticipated that out of 100 subjects recalled for additional breast imaging that 10 women will be recalled for biopsy. By adding 2D & 3D imaging, it is anticipated that 30 subjects out of 100 will have needed no workup. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment:

136

Study Start Date:

March 2009

Estimated Primary Completion Date:

March 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Device: Digital Breast Tomosynthesis

Women with a positive screening mammogram called back for additional views will be asked to undergo an additional Digital Breast Tomosynthesis (3D mammogram) on the affected breast. Radiation dose is somewhat less than that of a screening mammogram.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00826488